Ultragenyx Pharmaceutical

Biopharmaceutical

Director,CMCQA

$235–325k ~AI est. Novato, California, United States Remote Friendly
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Director candidates.

The Brief

“Director, CMC QA at Ultragenyx Pharmaceutical. Skills: CMC Quality, GMP Manufacturing, External Quality Assurance. Review/approve investigation of operations. Lead strategic discussion for investigations”

What You'll Achieve.

Ensure product quality; Meet cGMP regulatory requirements

Industry & Context.

Biopharmaceutical
Problems you'll solve

Root cause analysis; Creative solutions

Eligibility Requirements

10% travel

What They're Looking For.

Must Have

Bachelor's degree in Engineering, Biotechnology, Biological/Physical sciences, or equivalent, 10+ years GMP biopharmaceutical manufacturing experience, Working knowledge of FDA, EMA, local regulations, Working knowledge of Good Distribution Practices, Working knowledge of ICH guidelines, Working knowledge of industry best practice, Experience using risk management tools, Experience performing technical assessment of changes, Capability of engaging with Contract Organizations, Experience in biologic and small molecule drug development, Demonstrated high personal and professional ethical standards, Excellent judgment, Ability to think and act quickly, Ability to identify creative solutions, Ability to interpret and relate Quality standards, Ability to communicate clearly and professionally, Organizational and project management skills, Track record of meeting goals/objectives, Experience with regulatory authority inspections

Nice to Have

Master's degree preferred, Experience with mRNA therapeutics

What You'll Do.

Review/approve investigation of operations

Lead strategic discussion for investigations

Oversee resolution of quality events

Monitor recurrent events escalation

Ensure root cause is determined

Evaluate impact on product quality

Implement corrective actions

Review and approve changes

Perform final review of test data/reports

Drive execution of risk assessments

Manage product lifecycle

Address qualification requests

Engage with Tech Development

Address process development requests

Develop and maintain procedures

Maintain practices in compliance with regulations

Perform other duties as assigned

How You'll Work.

Team & Collaboration

External partnerships; Key stakeholders; Technical Operations; Tech Ops; Tech Development

Communication Scope

Written communication; Verbal communication

Process & Methodology

Project management

Full Job Description

Why Join Us? Be a hero for our rare disease patients At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won’t go – challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them. Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth – so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work. If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team. Position Summary: ultrafocused – Work together to fearlessly uncover new possibilities The Director, CMC QA will report to the Senior Director of CMC QA and be responsible for maintaining strategic responsibility over QA Manufacturing Operations, developing and implementing Ultragenyx CMC Quality approach for assigned programs, and working with colleagues to improve processes utilized to ensure product quality. In addition, this position will use strong management skills to independently manage external partnerships. In this role, in collaboration with key stakeholders in Technical Operations, DIR CMC QA provides quality oversight and support to ensure clinical through commer

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